Aditi Saini Email & Phone Number

As a Compliance Associate at CCRM, a leader in cell and gene therapy development and manufacturing, I am passionate about ensuring quality and compliance in a highly regulated environment. I have about 5 years of experience in managing electronic quality management systems (eQMS) in a good manufacturing practice (GMP) facility, where I excel in document and training management, supplier management, and internal/external audits.Some of my notable achievements include completing a "total protein" swab validation study that reduced the cost of allergen testing swabs by 81.25%, saving about $780,000 annually, and decreasing 75% of audit findings related to cGMP/GMP nonconformances by conducting frequent facility walkthroughs and coordinating with area owners.My core competencies encompass excellent time management, effective planning, project management, strong organizational skills, and exceptional communication abilities. I am result-driven, a team player, and possess strong problem-solving capabilities. I am proficient in various software tools, such as MasterControl, SureTrend Cloud, Intelex, POMSnet, SkyPrep, Asana, SharePoint, Adobe Acrobat Pro and Microsoft Office Suite.I have a solid educational background in biotechnology and pharmacy, having graduated with high honors from Centennial College with an Advanced Diploma in Biotechnology-Advanced, and from the University of Delhi with a Bachelor of Pharmacy. I am always eager to learn new skills and technologies, and to collaborate with diverse and talented teams. I am looking forward to connecting with you and exploring how my expertise in quality systems and dedication to delivering excellence can contribute to your organization's vision and mission.